Wako Direct Bilirubin V

by Wako Chemicals USA, Inc. United States 510(k)

510(k) K970986 Product code CIG

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK970986	Date7 May 1997Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number: K970986
FDA Product Code: CIG

Device Class: Class II
Regulation: 21 CFR Part 862.1110
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K970986 24 fields · synced 22 Oct 2026